Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 088786
Company: PAI HOLDINGS PHARM

Products on ANDA 088786

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
SODIUM POLYSTYRENE SULFONATE	SODIUM POLYSTYRENE SULFONATE	453.6GM/BOT	POWDER;ORAL, RECTAL	Discontinued	None	Yes	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 088786

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
09/11/1984	ORIG-1	Approval				Label is not available on this site.

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
11/08/1991	SUPPL-6	Labeling		Label is not available on this site.
01/30/1990	SUPPL-5	Labeling		Label is not available on this site.
08/29/1989	SUPPL-4	Labeling		Label is not available on this site.
03/06/1987	SUPPL-3	Manufacturing (CMC)		Label is not available on this site.
03/06/1987	SUPPL-2	Manufacturing (CMC)		Label is not available on this site.
05/23/1986	SUPPL-1	Manufacturing (CMC)		Label is not available on this site.